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The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Moderna COVID-19 Vaccine - United States, December 2020

Authors :
H. Keipp Talbot
Jose R. Romero
Beth P. Bell
Megan J. Wallace
Sarah Mbaeyi
Doug Campos-Outcalt
Grace M. Lee
Mona Marin
Rebecca L. Morgan
Kathleen Dooling
Sara E. Oliver
Nancy McClung
Mary Chamberland
Julia W. Gargano
Kathryn G. Curran
Source :
MMWR. Morbidity and mortality weekly report. 69(5152)
Publication Year :
2020

Abstract

On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 (mRNA-1273) vaccine (ModernaTX, Inc; Cambridge, Massachusetts), a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) (1). This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States (2). Vaccination with the Moderna COVID-19 vaccine consists of 2 doses (100 μg, 0.5 mL each) administered intramuscularly, 1 month (4 weeks) apart. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation* for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework,† using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.§ Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP's interim recommendations for allocating initial supplies of COVID-19 vaccines (3). The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.

Details

ISSN :
1545861X
Volume :
69
Issue :
5152
Database :
OpenAIRE
Journal :
MMWR. Morbidity and mortality weekly report
Accession number :
edsair.doi.dedup.....ee7deefd1c5ef01ad8b8d2373574e717